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COMPLETED Phase 2

Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer

NCT00513695 · View on ClinicalTrials.gov ↗

Study Summary

This phase II trial studies how well giving sunitinib malate together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide before surgery works in treating patients with stage IIB-IIIC breast cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib malate together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed

Interventions

  • DRUG cyclophosphamide
  • DRUG paclitaxel
  • BIOLOGICAL filgrastim
  • DRUG doxorubicin hydrochloride
  • DRUG sunitinib malate

Study Locations (7)

Washington

  • Skagit Valley Hospital — Mount Vernon
  • Olympic Medical Center — Port Angeles
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle

Alaska

  • Anchorage Oncology Centre — Anchorage
  • Katmai Oncology Group — Anchorage

Arizona

  • Arizona Cancer Center — Tucson

Idaho

  • Saint Luke's Mountain States Tumor Institute — Boise

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2007-06
Est. Completion 2017-10-16
Phase Phase 2

Sponsor

University of Washington

987 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00513695

The ClinicalTrials.gov registry entry for NCT00513695 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 987 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Stage II Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00513695 reports 7 study locations spanning 4 distinct geographic areas — top geographies include Washington, Alaska, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00513695 about?

NCT00513695 is a clinical study titled "Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer". This phase II trial studies how well giving sunitinib malate together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide before surgery works in treating patients with stage IIB-IIIC breast cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes need...

What is the current status of trial NCT00513695?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2007-06. Estimated completion is 2017-10-16.

What conditions does trial NCT00513695 study?

This clinical trial studies the following conditions: Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Male Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00513695?

The interventions under investigation include: cyclophosphamide (DRUG), paclitaxel (DRUG), filgrastim (BIOLOGICAL), doxorubicin hydrochloride (DRUG), sunitinib malate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00513695?

This trial is sponsored by University of Washington, which has 987 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00513695 being conducted?

This trial has 7 study locations across Alaska, Arizona, Idaho, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial